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MAPP on ANDA Facility Deficiency Reclassifiaction

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FDA posts a new CDER manual of policies and procedures (MAPP) 5021.5, Assessment of Facility-Based Deficiency Major-to-Minor Recla...

Linzess Approved for Pediatric Constipation

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FDA approves an Ironwood Pharmaceuticals supplemental NDA for Linzess (linaclotide) Linzess (linaclotide) to treat functional cons...

Info Collection on Regulatory Misconduct Allegations

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Federal Register notice: FDA seeks comments on an information collection extension on voluntarily submitted medical device regulat...

Wearable Smart Thermometer Recalled

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BearCare recalls it rechargeable Walnut Wearable Smart Thermometer due to reports about skin burns and irritation.

Phathom Pharma Resubmits Vonoprazan NDA

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FDA accepts for review a Phathom Pharmaceuticals NDA resubmission for vonoprazan, a potassium-competitive acid blocker to treat er...

GE Sonic DL Image Acquirer Cleared

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FDA clears a GE HealthCare 510(k) for the Sonic DL a deep learning-based technology designed to dramatically accelerate image acq...

Ferring Gene Therapy Scale-Up Approved

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FDA approves a Ferring Pharmaceuticals BLA supplement for intravesical gene therapy Adstiladrin and the companys plan to scale up ...

FDA Needs New Policies for AI: Gottlieb

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Former FDA commissioner Scott Gottlieb and his former chief of staff Lauren Silvis say FDA needs new policies geared toward integr...

FDA Alert on Oxygenator Recall

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FDA alerts health care providers and facilities on the use of oxygenators in extracorporeal circulation following a recent recall ...

Panel Backs Full Approval of Alzheimers Drug

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An FDA advisory committee votes 6 to 0 that data from the Phase 3 CLARITY AD trial verified the clinical benefit of Eisai/Biogens ...